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FDA 510(k)

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

K-Number: K192775 · 2019-10-30

ApplicantStereotaxis, Inc.
Decision Date2019-10-30
Product CodePJB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-10-30 under approval number K192775. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K192775.

When was Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri approved by the FDA?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri received FDA 510(k) clearance on 2019-10-30, under approval number K192775.

What company makes Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is manufactured by Stereotaxis, Inc..

What is the FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

The FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is PJB.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Stereotaxis, Inc.

K183027Steerable catheter control system K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) K250590MAGiC Sweep™ EP Mapping Catheter K253473Synchrony PMA P240014Cardiac ablation percutaneous catheter

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Related Devices (Code: PJB)

K183027Steerable catheter control systemStereotaxis, Inc. K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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